# The Human Medicines Regulations 2012, Regulation 298: Free samples for persons qualified to prescribe or supply medicinal products


(1) A person (“the supplier”) may not supply a free sample of a medicinal product to another person (“the recipient”) unless the following conditions are met.
(2) Condition A is that the recipient—
(a) is qualified to prescribe medicinal products; and
(b) receives the sample for the purpose of acquiring experience in dealing with the product in question.
(3) Condition B is that the sample is supplied to the recipient—
(a) on an exceptional basis; and
(b) in response to a request from, and signed and dated by, the recipient.
(4) Condition C is that, taking the year in which the sample is supplied as a whole, only a limited number of samples of the product in question are supplied to the recipient in that year.
(5) Condition D is that the sample—
(a) is no larger than the smallest presentation of the product that is available for sale—
(i) in the case of a medicinal product for sale or supply in Great Britain, in Great Britain, or
(ii) in the case of a medicinal product for sale or supply in Northern Ireland, in Northern Ireland;
(b) is marked “free medical sample – not for resale” or bears a similar description; and
(c) is accompanied by a copy of the summary of the product characteristics.
(6) Condition E is that the sample does not contain—
(a) a substance which is listed in any of Schedules I, II or IV to the Narcotic Drugs Convention (where the product is not a preparation listed in Schedule III to that Convention); or
(b) a substance which is listed in any of Schedules I to IV to the Psychotropic Substances Convention (where the product is not a preparation which may be exempted from measures of control in accordance with paragraphs 2 and 3 of article 3 of that Convention).
(7) Condition F is that the supplier maintains an adequate system of control and accountability in relation to the supply of free samples.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/298 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-298
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.